Tuesday, February 7, 2023

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Biotechnology News Magazine

CLINICAL TRIALS AND STUDIES

Janssen Announces Unblinding of Phase 3 CARTITUDE-4 Study of CARVYKTI® (cilta-cel) as Primary Endpoint Met in Treatment of Patients with Relapsed and Refractory Multiple...

"The CARTITUDE-4 study represents the first Phase 3 program in our comprehensive clinical development strategy for CARVYKTI, and further demonstrates our commitment to advance the treatment of patients with relapsed/refractory multiple myeloma," said Jordan Schecter, M.D., Vice President, Clinical Development Cellular Therapy Program, Janssen Research & Development, LLC. "We look forward to the presentation of the data from the CARTITUDE-4 study at a future medical meeting."

Decibel Therapeutics Announces Approval of Clinical Trial Application by the U.K. Medicines and Healthcare Products Regulatory Agency for Lead Gene Therapy Candidate DB-OTO

The CTA authorization for DB-OTO provides approval for the Company to expand its planned Phase 1/2 clinical trial to the U.K. in patients two years of age and younger

Agenus Presents Clinical Data Demonstrating Durable Responses of Botensilimab/Balstilimab Combination in Metastatic Microsatellite Stable Colorectal Cancer at ASCO GI

Overall response rate (ORR) of 23% and disease control rate (DCR) of 76% in expanded cohort of 70 heavily pre-treated patients; data suggest superior benefit compared to what has been reported for standard of care and other investigational therapies reports Agenus.

Iantrek Reports: 12-month Clinical Results of a Novel Micro-interventional Bio-stenting Procedure Published in the British Journal of Ophthalmology

"We are encouraged by the results of this study and the potential of this new approach to improve the lives of millions of people living with glaucoma worldwide," said Dr. Sean Ianchulev, Founder, Chairman, and CEO of Iantrek, as well as Professor of Ophthalmology at the Icahn School of Medicine at Mount Sinai and Director of Ophthalmic Innovation and Technology at the New York Eye and Ear Infirmary of Mount Sinai.

CytoSorbents Announces Health Canada Regulatory Approval For Pivotal STAR-T Trial

Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents commented, "We are very pleased to receive regulatory approval to expand STAR-T into Canada and are now working closely with our partners at the Population Health Research Institute to onboard up to 7 Canadian sites as soon as possible.

REGENXBIO Announces Phase I/II Trial of RGX-202, a Novel Gene Therapy Candidate for Duchenne Muscular Dystrophy, is Active and Recruiting Patients

RGX-202 is designed to deliver a transgene for a novel microdystrophin protein that includes the functional elements of the C-Terminal (CT) domain found in naturally occurring dystrophin. RGX-202 uses REGENXBIO's proprietary NAV® AAV8 vector.